Medical Device Assembly
A structured approach that adds value at each step
Introduction
To create successful assembly systems for the medical industry a company has to understand the unique challenges that are faced by manufacturers. Komax understands – we have over 40 years of experience and hundreds of successful installations. Our systems work in clean rooms, comply with FDA standards, and are usually validated by our own in-house staff of specialists.
Drawing on innovative technologies and our comprehensive knowledge of applications, Komax provides engineered solutions that support medical device projects at every stage in the product development life cycle – from concept, to prototyping, to pilot and high volume production, Komax has the tools and experience that allow present and future market leaders achieve their production goals.
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- A wide range of applications: inhalers, drugs and insulin delivery systems,
needles and catheters,
test and diagnostic instruments, etc.
- Modular system designs:
a wide range of automated assembly machines and platforms
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- Comprehensive knowledge of the critical processes in the assembly
of medical devices
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- A wealth of experience in supporting FDA validation (DQ, IQ, OQ and PQ)
and in questions relating to compatibility with 21 CFR 820 (GMP) and 21 CFR Part 11
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- State-of-the-Art Manufacturing Systems for the Test Strip Industry
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